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Sponsors and Collaborators: |
University of Pittsburgh Agency for Healthcare Research and Quality (AHRQ) |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00177437 |
This is a randomized controlled trial to determine whether a home screening test for chlamydia and gonorrhea will lead to increased use of screening tests and increased detection of sexually transmitted diseases.
Condition | Intervention | Phase |
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Chlamydia Trachomatis Gonorrhea |
Behavioral: home testing kit |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Single Group Assignment |
Official Title: | Home Screening for Chlamydia Surveillance |
Estimated Enrollment: | 403 |
Study Start Date: | June 1999 |
Study Completion Date: | September 2005 |
This is a phase III randomized controlled trial. We enrolled 403 young women from a variety of clinical settings and neighborhoods in the Pittsburgh, PA region. Women completed a baseline questionnaire and then were randomized to either an intervention group (receive home testing kit every six months) or to a control group (receive a letter suggesting a clinic visit for screening). Participants were followed for 2 years, and medical chart abstraction was done to document tests done in clinical settings. The final study end points were number of tests completed, number of screening tests completed, number of STDs detected, and incident cases of pelvic inflammatory disease.
Ages Eligible for Study: | 15 Years to 29 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria: age 15 to 29, 2 or more risk factors for STDs, sexually active -
Exclusion Criteria: currently pregnant, homeless
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United States, Pennsylvania | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Roberta B Ness, MD, MPH | University of Pittsburgh |
Study ID Numbers: | 0404024 |
Study First Received: | September 12, 2005 |
Last Updated: | December 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00177437 History of Changes |
Health Authority: | United States: Institutional Review Board |
Genital Diseases, Female Bacterial Infections Sexually Transmitted Diseases Chlamydia Infections |
Gonorrhea Genital Diseases, Male Neisseriaceae Infections Gram-Negative Bacterial Infections |
Genital Diseases, Female Bacterial Infections Sexually Transmitted Diseases, Bacterial Chlamydiaceae Infections Sexually Transmitted Diseases Chlamydia Infections |
Gonorrhea Genital Diseases, Male Infection Neisseriaceae Infections Gram-Negative Bacterial Infections |